NCT04477863

Brief Summary

The main purpose of this study is to perform longitudinal evaluations of clinical outcomes and personal perspectives following utilization of preimplantation genetic testing (PGT). Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. A licensed genetic counselor will conduct a recorded interview.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
300mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Jul 2020Dec 2050

Study Start

First participant enrolled

July 11, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
30 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2050

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

30 years

First QC Date

July 15, 2020

Last Update Submit

August 19, 2025

Conditions

InfertilityGenetic DiseaseIVF

Keywords

PGTFollow-up

Outcome Measures

Primary Outcomes (1)

  • Patient perspectives on PGT

    Analysis of interview responses

    2 years

Interventions

Follow-up InterviewOTHER

Non Applicable

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who undergo IVF and Preimplantation Genetic Testing

You may qualify if:

  • Patients indicating willingness to participate in research during informed consent to perform PGT

You may not qualify if:

  • Patients who opted out of participating in research during informed consent to perform PGT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genomic Prediction Clinical Laboratory

North Brunswick, New Jersey, 08902, United States

RECRUITING

Related Links

MeSH Terms

Conditions

InfertilityGenetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Nathan R Treff, PhD

    Genomic Prediction

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Talia Metzgar, RN

CONTACT

(973) 529-4223Talia@genomicprediction.com

Bhavini Rana

CONTACT

(973) 529-4223bhavini@genomicprediction.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 20, 2020

Study Start

July 11, 2020

Primary Completion (Estimated)

July 11, 2050

Study Completion (Estimated)

December 31, 2050

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings.

Shared Documents
CSR
Time Frame
August 2020

Locations

US(1)